Medication info
Tapagyn Plus Sustained Release Tablet 10/1000mg

Tapagyn Plus Sustained Release Tablet 10/1000mg

Prescription medicationTablet경구
Ingredient · strength
Metformin Hydrochloride›1000mg / 1 tabletDapagliflozin Propanediol Hydrate›12.3mg / 1 tablet
Manufacturer / importer
대화제약(주)
Appearance
Yellow, double convex, oval-shaped sustained-release film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202300230 · Approved 2023.01.12 · Insurance code 645605780

Summary

Main use
Blood sugar control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
This medication is generally administered once daily with the evening meal. The maximum dosage is once daily dapagliflozin 10mg/sustained-release metformin 2000mg. The recommended starting dose for initial therapy is 5mg/500mg or 10mg/500mg once daily. The dosage is adjusted gradually to reduce gastrointestinal side effects of metformin. For patients undergoing prior metformin therapy, the dapagliflozin recommended dose is once daily 10mg and the dosing of this medication should be closely aligned with the therapeutic dose of metformin that was being taken.

Ingredients

Manufacturer
대화제약(주)

Efficacy & effects

Blood sugar control in type 2 diabetes and prevention of cardiovascular events

  • Type 2 diabetes
  • abnormal blood sugar control
  • cardiovascular disease
  • cardiovascular risk factors
View approved original text

This medication is used to aid the blood sugar control of adult patients with type 2 diabetes in conjunction with meal and exercise therapy through the combined administration of dapagliflozin and metformin. It is especially administered for patients whose blood sugar remains inadequately controlled and who have cardiovascular disease or risk factors, considering the risk of cardiovascular events. Therefore, this medication helps effectively improve blood sugar levels in patients with type 2 diabetes.

How to take

Adult dose

This medication is generally administered once daily with the evening meal. The maximum dosage is once daily dapagliflozin 10mg/sustained-release metformin 2000mg. The recommended starting dose for initial therapy is 5mg/500mg or 10mg/500mg once daily. The dosage is adjusted gradually to reduce gastrointestinal side effects of metformin. For patients undergoing prior metformin therapy, the dapagliflozin recommended dose is once daily 10mg and the dosing of this medication should be closely aligned with the therapeutic dose of metformin that was being taken.

Precautions

This medication is used to treat diabetes and helps to control blood sugar levels. During treatment with this medication, very rarely, a serious condition known as lactic acidosis may occur, so caution is required. Lactic acidosis can lead to an excessive accumulation of lactic acid in the body, resulting in a dangerous condition, and can sometimes be life-threatening. Additionally, when taken with other diabetes medications such as insulin or sulfonylureas, hypoglycemic symptoms may occur, thus blood sugar levels should be closely monitored. Patients with impaired kidney function, dehydration, severe infections, or heart problems should not take this medication. Use of this drug is prohibited in patients with severe impairment of kidney function. If surgery is imminent or if there are plans for tests using iodine contrast agents, this medication should be temporarily discontinued for a period of time and only resumed after confirming that kidney function has returned to normal. Pregnant or nursing women should not take this medication, nor should patients with specific genetic disorders such as lactose intolerance. This medication may cause side effects such as reduced fluid volume, low blood pressure, and changes in kidney function; therefore, particularly in elderly patients or those with weak kidney function, it's essential to consult with a doctor before taking it and to undergo regular kidney function tests. During treatment, there may be occurrences of genital infections or urinary tract infections, so if any symptoms of infection appear, medical professionals should be notified immediately. This medication may also lower vitamin B12 levels, so if taken for an extended period, it is recommended to check vitamin B12 levels through blood tests. Excessive alcohol intake may increase the risk of side effects from this medication and should be avoided. During treatment, be alert for hypoglycemic symptoms, and if dizziness or weakness occurs, consult a doctor immediately. Finally, this medication has not been established as safe and effective for children, so it is not used in this population. It is important to consult with a physician or pharmacist before taking this medication to verify the appropriate usage and precautions corresponding to individual health conditions.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, pain in oral/eye mucous membranes, shortness of breath or difficulty breathing, asthma attack, abnormal breathing accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination

Mild side effects

Dizziness, constipation, dry mouth, back pain, painful urination, polyuria, nocturia, vulvar itching, genital itching, increased hematocrit, dyslipidemia, increased serum creatinine, increased serum urea, weight loss, hypoglycemia (when used with sulfonylureas or insulin), infection symptoms (vulvovaginitis, balanitis, fungal infection, urinary tract infection, nasopharyngitis, pharyngitis, adenoviral conjunctivitis, herpes zoster, bacterial pneumonia, pneumonia)

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture, at a room temperature between 1 to 30 degrees Celsius. By storing it this way, the effectiveness of the medication can be maintained for a longer period.

Appearance and packaging

Appearance

Yellow, double convex, oval-shaped sustained-release film-coated tablet

Package unit

30 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.